Hi, We're Formation Bio!

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

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About the Position

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As the Engineering Manager for our Data Acquisition Squad, you will be accountable for Engineering strategy, design, development, and implementation of one of our core data teams that is responsible for building pipelines, data models, and handling the ingestion of novel data sources to support the entirety of a clinical trial journey, from patient recruitment to submitting 

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Engineering leaders at Formation Bio operate along three dimensions to support business outcomes:

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People

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• Lead your engineering team accountable for delivering high-quality data products.
• Develop and mentor Data and Analytics Engineers.
• Foster a culture of collaboration and continuous improvement among your squad and contribute to the broader Engineering team.

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Process

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• Develop and implement best practices that drive efficiency, quality, and innovation within your squad.
• Optimize Engineering processes to achieve high levels of productivity and quality while reducing cycle time and technical debt for both your squad and data users within Formation Bio.
• Work with other teams such as Site Reliability Engineering and Product Engineering to establish and improve the software development and deployment lifecycle.

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Product

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• Partner with Product to align vision, strategy, and roadmap for your squad.
• Drive the execution of the roadmap by working closely with cross-functional teams.
• Ensure that products are built to be reliable and easy to maintain.
• Identify and mitigate technical risks and make sound decisions to ensure that the product is delivered on time and within budget.

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The ideal candidate is passionate about developing quality data products, enabling their team to be the best version of themselves, and committed to continuous improvement.

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About You

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Required:

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• 1-3 Years of Engineering Management
• 3-7 Years as an Individual Contributor
• Fluent in Python, Relational Databases, and ELT/ETL Concepts
• Familiar with Infrastructure as code such as cloud formation and terraform

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Preferred:

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• 2-3 Years of Engineering Management
• 5+ years as an Individual Contributor
• Experience with low/no code solutions such as Snowplow and Rivery
• Experience with DBT
• Experience with Looker

​

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We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $183,000 - $240,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

​

About the Role

​

The Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to developing and marketing Formation Bio’s assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support and the leadership of regulatory strategy for projects that are currently US focused, but potentially will extend globally, coordinating departmental and cross-functional support.

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Responsibilities

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• Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
• Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for Formation Bio's drug assets.
• Represents the Regulatory function on asset development teams.
• Leads the development of strategic plans and tactical implementation resulting in the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
• Provides Regulatory CMC guidance around drug development and manufacturing/supply processes.
• Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products in support of CMC applications.
• Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
• Provides guidance to all appropriate departments in Formation Bio to assure compliance with applicable regulations.
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.
• Makes recommendations for regulatory department operating procedures.
• Actively trains/mentors’ junior staff; provides broader guidance on regulatory interpretation to Formation Bio’s staff.
• Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.

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About You

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• BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
• Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas.  The regulatory experience should be broad (across the life cycle of pharmaceutical products, including clinical, non-clinical and CMC aspects of drug development, and across main regions such as US and EU) to ensure appropriate leadership.
• Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
• Ability to read, analyze and interpret scientific and technical information and regulatory documents.
• Ability to present complex issues in oral and written form.
• Experienced in responding to inquiries from HAs. (EMA & FDA)
• Extensive experience with biologics and/or small molecule.

​

​

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $295,000 - $340,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

​

About the Position

​

As the Director, Program Management, you will be a hands-on leader with a passion for driving results across a highly cross-functional team.  

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You will be responsible for directing the strategic and operational planning within Formation Bio’s emerging drug development team(s). In this leadership role, you will partner with the Program Team Leader and cross-functional Program Development Team (PDT) by providing program management excellence to ensure the development of a unified strategic vision and drive the team to successfully execute on the agreed strategy. 

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You will be an expert in robust cross-functional planning and alignment, facilitate decision-making and drive the implementation, monitoring, and reporting for one or more programs. 

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You will provide content expertise on the timing, costs and resources required to deliver to the defined program strategy, anticipate potential obstacles in the program and facilitate risk: benefit discussions driving the team to a clear direction and path forward. In this role, the Director program management will act as an operational leader to help the team achieve established objectives, facilitate governance interactions, and organize the needed tactics to make the program and associated projects a success. The Director, PM may be responsible for one or more programs with significant complex cross-functional and/or cross-program initiatives within Formation Bio’s pipeline.

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Responsibilities

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• Strategic and tactical partner to the Program Team Leader and line function representatives accountable to establish and deliver an aligned Global Strategic Development Plan across all relevant development functional groups into a cohesive and strategic development plan to deliver the agreed target product profile.
• Work closely with the Project Team Leader to facilitate the elaboration, approval and execution of the global program development strategy and facilitate decision-making process through to senior leadership team via the company’s governance process
• Coordinate and drive development process planning activities of the program team including milestone setting, strategic integrated development plans, long-range plans, budget inputs and go/no go criteria as appropriate.
• Ensure transparency and understanding of the approved plan horizontally and vertically throughout the organization. Prepare and manage governance interactions with the Program Team Leader and ensure timely input of program status/risks/issues throughout the organization.
• Maintain the overall development plans for assigned program(s).
• Maintain all project management tools with focus on Program and Portfolio Management Systems (including SmartSheet).
• Facilitate team meetings/agendas/minutes/action items including decision and action logs.
• Coordinate team goal setting and tracking to ensure adherence to plan and agreed end of year milestones.
• Partner with the VP, Program Management and other functional leaders to assess program and project management processes to ensure best practices are employed for the needs of TrialSpark.

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About You

​

• At least 7 years of experience within one or more functional role(s) in pharmaceutical R&D drug development, biotechnology drug development, or related industry.
• At least 5 years of cross-functional program/project management experience
• Experience in Dermatology, Neurology, Endocrinology, or Psychiatry therapeutic area preferred
• Proven track record of planning and managing complex programs in different phases of development including cross-functional deliverables.
• Demonstrated ability to provide effective project management leadership in terms of setting project plans for the lifecycle of a program from discovery through launch
• Excellent leadership skills with a history of delivering in a dynamic environment
• Independent creative thinker and enabler requiring minimum oversight
• Solid understanding of the processes in drug development and appropriate regulatory guidelines
• Strong influencing and interpersonal skills including negotiation, managing meetings and group dynamics, ability to balance concerns of line management with objectives of cross-functional team
• Demonstrated understanding of program risk management and mitigation in order to simulate the likely obstacles to program progression
• Excellent communication skills (written and verbal communication skills in English)
• Strong organizational skills with the ability to deal with competing priorities; high level of problem-solving capability and business acumen, ability to balance competing priorities and quickly and objectively drive the team towards a path which maximizes value
• Strong technical proficiency in the use of project planning tools and systems (including Smartsheet), resource forecasting, and the use of reporting tools
• Smartsheet Certification-preferred or ability to achieve certification within 30 days of employment
• PMP certification preferred
• Competency in MS Office / Google Suite software applications (e.g. MS Word, MS Powerpoint, MS Excel, Google Docs, Google Sheets, etc.)
• Highly skilled in negotiation, facilitation, and managing matrix team dynamics

​

​

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $242,000 - $280,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

​

About the Role

​

The Director, Drug Substance Development, will be responsible for directing the Drug Substance process development and manufacturing activities at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 to Phase 3, as well as registration and validation.

​

Responsibilities

​

• Design and execute drug substance development and manufacturing strategies that deliver drug substance on-time/in-full when needed while preparing for the future.
• Devise detailed plans for drug substance process development/optimization, scale-up and validation in a phase-appropriate manner and execute them at chosen contract service providers/partners.
• Set clear outcomes/deliverables for projects with the larger TrialSpark team and own them, staying accountable to all internal stakeholders.
• Mentor direct reports and team members (internal as well as external) in a way that assures desired project outcomes while developing and providing opportunities for rising talent.
• Prepare budget, manage financials, and forecast drug substance expenditures (including expenditures with CMOs and consultants)
• Author, review, and provide strategic input for regulatory filings (including INDs, IMPDs, NDAs, briefing packages and other regulatory dossiers) and updates.
• Prepare for and participate in meetings with the FDA or other regulatory bodies as needed.
• Develop strategic and beneficial relationships with CMOs, RM suppliers, consultants, etc. and actively manage/oversee these external parties.  Regularly evaluate and provide recommendations to senior management for changes and/or any new alliances.
• Review and approve technical documents (e.g., CGMP documentation with CMOs) in a timely manner.
• Stay current on industry trends, practices and regulatory guidance.
• Manage priorities and timelines while also creating value by devising new possibilities and practicing the best/most practical technologies, including the use of QbD and PAT where appropriate.
• Create new systems/policies with an eye on Continuous Improvement and oversee these for compliance and efficiencies.
• Evaluate and judge performance of direct reports, team members, consultants, CMOs, provide effective feedback and coaching as and when needed, and build effective teams.
• Provide direction/oversight for EHS related matters and mitigate/manage risks related to chemical process safety and occupational health handling of Drug Substances.
• When appropriate, lead cross-functional needs to meet internal customers’ requirements/ timelines including chemistry, toxicology, analytical (including stability) and drug product development, and accordingly provide appropriate support to management.
• Provide presentations and updates as necessary to the leadership team.

​

Relevant Experience

​

• Ph.D. in chemistry with at least 15 years of related technical (process chemistry, problem solving, scale-up) and management experience and 10 years work experience in the pharmaceutical/biotech industry.
• Prior experience selecting and working with domestic and international CMOs and consultants. A thorough understanding of synthetic and process chemistry and solid form science.
• Experience and working knowledge in early-phase, late phase development, and validation.
• Excellent writing skills as they relate to preparation of RFPs, protocols, and reports.
• Experience with the preparation of regulatory documents is a must.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• Excellent problem-solving skills and analytical thinking capabilities.
• Developed leadership attributes such as a high level of emotional intelligence, strategic thinking, effective listening, and decision making, anticipation and risk management, questioning the status quo, mentorship, focus on continuous improvement, etc.
• Ability to communicate difficult concepts, ideas and solutions to senior leaders in other scientific disciplines.
• Keen level of self-awareness, a desire to learn new skills/knowledge and to effectively participate/lead cross-functional teams.
• A strong understanding of CGMP requirements and ICH and regulatory guidance.
• Familiarity of Quality and Regulatory Affairs as applicable to CMOs compliance and regulatory filings.
• Well versed with the latest trend in technologies and the outsourcing industry

​

Travel

​

Travel may be required up to 25-30% of your time.

​

​

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $247,000 - $280,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

​

About the Role

​

As the Director of Drug Product, you will spearhead the strategic direction and execution of drug product development and manufacturing activities at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 to Phase 3, as well as registration and validation. Your role will be pivotal in orchestrating the design, optimization, and validation of drug product processes while ensuring alignment with regulatory standards and company objectives. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to drive successful drug product development and manufacturing operations.

​

Responsibilities

​

• Design and implement robust drug product development and manufacturing strategies, ensuring timely and efficient delivery. Plan for future needs while optimizing current processes.
• Devise comprehensive plans for process development, optimization, scale-up, and validation, ensuring phase-appropriate execution at chosen service providers. Maintain a high standard of quality and compliance.
• Prepare budgets, manage financials, and forecast expenditures related to drug product activities, including expenditures with contract manufacturing organizations (CMOs) and consultants.
• Mentor and guide both internal and external team members, fostering talent growth while ensuring project success and desired outcomes. Evaluate performance, provide feedback, coach team members, and build effective cross-functional teams. Mentor them in all matters related to drug product development and manufacturing.
• Define project deliverables, take ownership, and ensure accountability to internal stakeholders. Collaborate with the broader team to achieve set outcomes.
• Author, review, and strategically contribute to regulatory filings and updates. Cultivate strategic relationships with CMOs, suppliers, and consultants, providing oversight and recommendations for alliances.
• Author and review technical documents, staying abreast of industry trends, regulations, and best practices. Drive the adoption of innovative technologies and quality-by-design (QbD) approaches.
• Lead cross-functional efforts to meet internal customer requirements and timelines, coordinating activities across chemistry, toxicology, analytical, clinical pharmacology, and drug product development.
• Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations.
• Provide presentations and reports on progress on multi-disciplinary development teams, as necessary to the leadership team.

​

Relevant Experience

​

• Advanced degree (Ph.D., Master’s) in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline or engineering with a minimum of 15 years’ technical and managerial experience, with 10 years in pharmaceutical/biotech industry roles.
• Extensive formulation and process development expertise, including scale-up, and validation.
• Experience with the development and manufacturing of topical formulations, solid oral dose and sterile products (small molecules and biologics)
• Demonstrated experience in selecting and collaborating with domestic and international CMOs and consultants.
• Demonstrated leadership and management skills, with prior experience managing internal resources.
• Manufacturing experience and a good understanding of cGMP requirements
• Proficient in writing RFPs, protocols, reports, and regulatory documents.
• Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills.
• Leadership qualities including emotional intelligence, strategic thinking, mentorship, and continuous improvement focus.
• Sound knowledge of CGMP, ICH guidelines, regulatory affairs, and industry trends.
• Understanding of drug substances, solid form science, and analytical chemistry as related to drug product development.
• Excellent interpersonal skills, including negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• Excellent risk management, problem-solving and crisis management skills
• Ability to work in cross-functional teams as related to drug development.
• Well versed with the latest technologies, trends and practices in formulation development, manufacturing, and the outsourcing industry

​

Travel

​

Travel may be required up to 25-30% of your time.

​

​

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $247,000 - $280,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

​

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

​

About the Role

​

As the Director of Analytical Development and QC, you will spearhead the strategic direction and execution of analytical research and development and quality control activities for active pharmaceutical ingredients (API) and drug product (DP) at Formation Bio and our contract R&D and manufacturing partners for assets in Phase 1 to Phase 3. You will oversee all API and DP release stability testing as well as analytical   regulatory documentation to support global clinical studies.  Your role will be pivotal, ensuring alignment with regulatory standards and company objectives. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory background.

​

Responsibilities

​

• Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners.
• Oversee the establishment of testing methodology specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs including trend analysis, and retesting strategy for clinical trial materials.
• Prepare budgets and forecast expenditures related to drug substance and drug product analytical development activities, including expenditures with contract manufacturing organizations (CMOs) and consultants.
• Mentor and guide both internal and external team members, fostering talent growth while ensuring project success and desired outcomes. Evaluate performance, provide feedback, coach team members, and build effective cross-functional teams. Mentor them in all matters related to drug product development and manufacturing.
• Define project deliverables, take ownership, and ensure accountability to internal stakeholders. Collaborate with the broader team to achieve set outcomes.
• Author, review, and strategically contribute to regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).
• Support, in collaboration with Quality Control and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners.
• Cultivate strategic relationships with CMOs, suppliers, and consultants, providing oversight and recommendations for alliances.
• Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones.
• Author and review technical documents, staying abreast of industry trends, regulations, and best practices. Drive the adoption of innovative technologies and quality-by-design (QbD) approaches.
• Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports.
• Work in close collaboration and support with other members of the CMC team responsible for API and DP development and support to management as necessary.
• Work with Drug Substance and Drug product colleagues, as well as QA in the selection of CDMOs partners for all stages of development.
• Develop strong relationships with external said partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
• Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations.
• Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations.
• Provide presentations and reports on progress on multi-disciplinary development teams, as necessary to the leadership team.

​

About You

​

• A PhD in analytical chemistry or related field with at least 15 years of analytical/CMC team leadership in the CDMO, biotechnology or pharmaceutical industry.
• Experience in Contract Research Organizations and/or contract laboratory relationship management.
• Extensive technical expertise in analytical development and validation for API and DP, characterization, and stability of a variety of formulations including solid oral dose, dermal, and injectable.
• Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification establishment. Thorough understanding of phase appropriate methods qualification and/or validation and specifications for APIs and DPs.
• Manufacturing experience and a good understanding of cGMP requirements
• Proficient in writing RFPs, protocols, reports, and regulatory documents.
• Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills.
• Leadership qualities including emotional intelligence, strategic thinking, mentorship, and continuous improvement focus.
• Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability.
• Excellent interpersonal skills, including negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• Excellent risk management, problem-solving and crisis management skills.
• Ability to work in cross-functional teams as related to drug development.
• Must be well organized, proactive, and detail-oriented.
• Demonstrated leadership and management skills, with prior experience collaborating with and directing the work of others on assigned projects (including both internal teams and external collaborators) in multiple CMC programs.
• Well versed with the latest technologies, trends and practices in analytical development, manufacturing, and the outsourcing industry.

​

Travel

​

Travel may be required up to 25-30% of your time.

​

​

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $240,000 - $280,000.

​

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

​

If this range doesn’t match your expectations, please still apply because we may have something else for you.

​

---

​

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

​

About Formation Bio

​

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

​

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

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Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

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Responsibilities

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• Lead the design, development, and deployment of software solutions that leverage AI and LLM technologies in the strategic drug development process.
• Collaborate with cross-functional teams, including product managers and domain experts, to discover, build, and iterate on innovative features and products.
• Ensure the scalability, security, and performance of our software systems.
• Rapidly develop and iterate on proofs-of-concept to test new ideas and hypotheses to efficiently validate and evolve our software solutions in alignment with strategic objectives in drug development.
• Stay abreast of emerging trends and advancements in AI, LLMs, and software development to continually enhance our product offerings.
• Act as an internal evangelist for use of AI and LLMs, providing expert guidance and insights to other teams within the organization.

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About You

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• Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field, or equivalent experience.
• Minimum of 5 years of experience in software development, with a demonstrated ability to thrive in ambiguous and rapidly-changing environments, with a proven track record of contributing significantly to the successful launch and scaling of new and innovative products, especially in a 0-1 setting.
• Exceptional collaboration and communication skills to effectively engage and work along stakeholders from diverse disciplines and varying levels of technical expertise. Ideally, adept at translating complex technical concepts into clear, actionable insights for all audiences.
• Experience with AI technologies, particularly in LLMs and machine learning.
• Familiarity with cloud infrastructure (e.g., AWS, Azure, GCP) and the full end-to-end process of modern software deployment (e.g., containerization, CI/CD).
• Experience in the pharmaceutical or biotech industry is a plus, but not required

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We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $186,000 - $240,000.

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On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

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If this range doesn’t match your expectations, please still apply because we may have something else for you.

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You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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